ISO 14971:2019 Overview

Course instructor:
Bob Deysher – Senior Consultant, Quality Systems/Risk Management/Auditing

Course Description
ISO 14971:2019 “Medical devices — Application of risk management to medical devices” defines a standard process for identifying risks associated with medical devices at all stages in a device’s life cycle, from product design to production and post production use. The goal of ISO 14971:2019 develop a risk management plan that is capable of assessing, evaluating, identifying controls, and monitoring the risks associated with each life-cycle stage.

To help understand ISO 14971:2019 the course will use ISO 24971:2020 “Medical devices— Guidance on the application of ISO 14971” which is a companion document. Tools and techniques described in ISO 24971:2020 will be used to demonstrate how risks can be assessed and evaluated.

Finally the course will review ISO 13485:2016, “Medical devices — Quality management systems —Requirements for regulatory purposes” where the concepts from ISO 14971:2019 and ISO 24971:2020 can be applied.

Who Should Attend?
This course is designed for Internal Auditors, Quality Assurance Managers, ISO 13485:2016 Implementation Team Members, Management Representatives, and individuals who wish to learn how to apply risk management tools and techniques utilizing ISO 14971:2019 and ISO 24971:2020

Leaning Objectives:
Upon completion of this training, participants will be able to:

  • Describe the Risk Management Process as defined in ISO 14971:2019
  • Identify how ISO 14971:2019 relates to ISO 13485:2016 Risk Management Requirements
  • Leverage the relationship of ISO TIR 24971:2020 to ISO 14971:2019
  • Identify and Quantify Risks for their Organization
  • Apply Risk Management Tools and how they align with the Product Life Cycle and requirements in ISO 13485:2016

Course Outline

  • Applicability of ISO 14971:2019
  • Structural Changes of ISO 14971:2019
  • Changes and Additions to ISO 14971:2019
  • Changes and Additions to ISO 24971:2020
  • Detailed Analysis of ISO 14971:2019 with reference ISO 24971:2020 Tools and Techniques
    • Clause 1 Scope
    • Clause 2 Normative References
    • Clause 3 Terms and Definitions
      • Exercise #1 Terms & Definitions
    • Clause 4 General Requirements
      • Risk Management Plan Example
    • Clause 5 Risk Analysis
    • Clause 6 Risk Evaluation
      • Tools during Product/Service Life Cycle
      • Exercise #2 Supplier Risk Assessment (ISO 13485)
    • Clause 7 Risk Control
      • Control Options
      • Benefit-Risk Examples
    • Clause 8 Evaluation of Overall Risk
    • Clause 9 Risk Management Review
      • Overall/Total Residual Risk
      • Risk Management Review
    • Clause 10 Production and post production activities
  • ISO 13485:2016 and Risk Management
    • Exercise #3 – Risk Application – Customer Complaints
    • Exercise #4 – Training Exercise – Risk
  • ISO 14971:2019 Conclusions

Course format:
8:30am-4:30pm (EST)
Location: QSG Training Facility
319 Littleton Road #206, Westford, MA 01886
(During COVID-19 pandemic this class will be virtual)


Payment Type:
Date Attending
Name of Attendee(s)
Name of Company




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